Interchangeable Guide in Ridge Splitting Flapless Technique for Implant Placement

Not Applicable

Completed

• Conditions: Anterior Maxillary Narrow Ridge
• Interventions: Procedure: ridge splitting flapless technique using interchangeable guide followed by implant placement

• Registration Number: NCT04386382
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow ridges after ridge splitting flapless technique using an interchangeable guide.

Detailed Description

A sample was selected conveniently to fulfill a list of inclusion and exclusion criteria. Then the selected participants underwent ridge splitting with the aid of interchangeable guide. After ridge splitting, all patients had simultaneous implant placement followed by clinical and radiographical evaluation over a period of 6 months.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-04-10
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients with anterior maxillary narrow ridge
• Patients with adequate alveolar ridge bone height
• Age ranging from 20-40 years.
• Patients should have adequate oral hygiene
• Patients should be free of soft tissue or oral dental pathology
• Patients who accept to participate in the study.

Exclusion Criteria

• Patients suffering from relevant systemic and/or metabolic diseases
• Patients suffering from immunosuppressive and/or autoimmune diseases
• Heavy smokers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ridge splitting flapless technique using interchangeable guide	ridge splitting flapless technique using interchangeable guide followed by implant placement	Fabrication of interchangeable surgical guide stent: * Optical scanning of the dental casts was done using Ceramill map 400 * The treatment plan and the surgical stent were designed using Mimics Innovation Suite 19 ™ software * Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	After 1 week	Visual Analouge Scale (VAS) 0=no pain; 1. mild pain; it is easily tolerated; 2. moderate pain; it is causing discomfort but bearable.; 3. severe pain; it is causing discomfort, hardly tolerated and unbearable.
Change of bone width from baseline measurements	Baseline, 1 week, 3 months and 6 months	Cone beam computed tomography (CBCT) was used to evaluate bone width and density to all patients by doing CBCT at time intervals
Clinical evaluaion	After 1 week	post operative complication (presence or absence of any sign of swelling or infection)

Secondary Outcome Measures

Name	Time	Method
operation time	During the procedure	Evaluation of the operating time

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt